States Will Receive $14M in Paxil Lawsuit
GlaxoSmithKline on Tuesday agreed to pay $14 million to states to settle allegations that the company blocked generic versions of its antidepressant Paxil, causing state health programs to pay higher prices, the AP/Philadelphia Inquirer reports. Attorneys general of 49 states and Washington, D.C., filed suit alleging that GSK used frivolous lawsuits against generic drug makers, leading to automatic extensions of Paxil's patent (Robrish, AP/Philadelphia Inquirer, 3/29).
The states' suit, filed in federal court in Philadelphia on Monday, sought to recover excess Paxil expenditures by Medicaid between 1997 and 2003. The suit claimed that GSK's original patent for Paxil, which was due to expire in 1997, had always been questionable.
GSK acquired rights to the drug in 1980, and the patent was due to expire in 1992. However, GSK obtained a new patent in 1980 on a slightly different version of the drug that contained an extra water molecule, which gave the company exclusive rights to sell the drug for five additional years.
The attorneys general argued that when that period expired, GSK developed a dozen new patent applications covering slightly different versions of Paxil's active ingredient, which triggered an automatic hold on FDA approvals of generic versions.
In addition, GSK filed a suit against generic manufacturers that were attempting to market a cheaper version of Paxil, a move that the attorneys general called "sham litigation." GSK later withdrew three patent applications, allowing a generic version to reach the market in September 2003.
GSK recently agreed to pay $165 million to settle two similar suits regarding Paxil's patent extensions, one brought by pharmacies and another by consumers and private insurers (Tansey, San Francisco Chronicle, 3/29).
West Virginia was the only state that did not participate in the attorneys general's suit (AP/Philadelphia Inquirer, 3/29).
Under the settlement, California will receive $2 million, the largest amount that any state or government entity will receive, the Chronicle reports.
Tom Dresslar, a spokesperson for Attorney General Bill Lockyer (D), said Lockyer would determine how the settlement would be distributed among state entities that purchased Paxil at inflated prices (San Francisco Chronicle, 3/29).
The entities include Medi-Cal, University of California medical centers and the Departments of Health Services and General Services (McIntoch, Sacramento Bee, 3/29).